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Peer-reviewedCC BY-NC-NDInternational Journal of Ophthalmology

Efficacy of teprotumumab N01 (IBI311), an IGF-1R inhibitor, for thyroid eye disease patients who had failed glucocorticoids

5 affiliations
  1. 1Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing 100044, China
  2. 2Department of Ophthalmology, Peking University People's Hospital, Eye Diseases and Optometry Institute, Beijing Key Laboratory of Diagnosis and Therapy of Retinal and Choroid Diseases, College of Optometry, Peking University Health Science Center, Beijing 100044, China
  3. 3Department of Endocrinology and Metabolism, Shanxi Province Fenyang Hospital, Fenyang 032200, Shanxi Province, China
  4. 4Department of Radiology, Peking University People's Hospital, Beijing 100044, China
  5. 5Innovent Biologics, Inc., Suzhou 215123, Jiangsu Province, China

Abstract

AIM: To explore the efficacy of teprotumumab N01 (IBI311), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, in thyroid eye disease (TED) patients who had failed glucocorticoids. METHODS: In this pilot case series study, patients with TED failing intravenous or oral glucocorticoid treatments were treated with teprotumumab N01 (10 mg/kg for the first infusion then 20 mg/kg every 3wk for subsequent 3 infusions). Proptosis, clinical activity score (CAS), Gorman diplopia score, magnetic resonance imaging (MRI), adverse events and laboratory tests were evaluated during the treatment. RESULTS: The patients' mean age was 38.7y, 6 of 10 were female, and TED duration of these patients ranged from 0.8 to 5y. At week 12, 7 patients had proptosis response, 6 achieved a CAS of 0 or 1 and 5 achieved an overall response. For patients with proptosis improvement, MRI also showed consistent changes including volume decrease of extraocular muscles and orbital fat tissues. The incidence of adverse events was low. CONCLUSION: Teprotumumab N01 infusions result in proptosis response and clinical activity improvements accompanied with favorable safety profile in TED patients who had failed glucocorticoids. Randomized controlled trials will be conducted to further assess the efficacy and safety of teprotumumab N01 in TED patients.

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BibTeX
@article{zhao2026efficacy,
  title = {{Efficacy of teprotumumab N01 (IBI311), an IGF-1R inhibitor, for thyroid eye disease patients who had failed glucocorticoids}},
  author = {Wei Zhao and Tian-Yuan Li and Ying Na and Xin-Yi Gou and Ling-Li Zhou and Yi-Hua Xu and Jin Cheng and Xiu-Ying Zhang and Li-Nong Ji},
  journal = {International Journal of Ophthalmology},
  year = {2026},
  month = nov,
  doi = {10.18240/ijo.2026.11.22},
  url = {https://doi.org/10.18240/ijo.2026.11.22},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Efficacy of teprotumumab N01 (IBI311), an IGF-1R inhibitor, for thyroid eye disease patients who had failed glucocorticoids
AU  - Wei Zhao
AU  - Tian-Yuan Li
AU  - Ying Na
AU  - Xin-Yi Gou
AU  - Ling-Li Zhou
AU  - Yi-Hua Xu
AU  - Jin Cheng
AU  - Xiu-Ying Zhang
AU  - Li-Nong Ji
PY  - 2026
DA  - 2026/11/02
JO  - International Journal of Ophthalmology
DO  - 10.18240/ijo.2026.11.22
UR  - https://doi.org/10.18240/ijo.2026.11.22
AB  - AIM: To explore the efficacy of teprotumumab N01 (IBI311), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, in thyroid eye disease (TED) patients who had failed glucocorticoids. METHODS: In this pilot case series study, patients with TED failing intravenous or oral glucocorticoid treatments were treated with teprotumumab N01 (10 mg/kg for the first infusion then 20 mg/kg every 3wk for subsequent 3 infusions). Proptosis, clinical activity score (CAS), Gorman diplopia score, magnetic resonance imaging (MRI), adverse events and laboratory tests were evaluated during the treatment. RESULTS: The patients' mean age was 38.7y, 6 of 10 were female, and TED duration of these patients ranged from 0.8 to 5y. At week 12, 7 patients had proptosis response, 6 achieved a CAS of 0 or 1 and 5 achieved an overall response. For patients with proptosis improvement, MRI also showed consistent changes including volume decrease of extraocular muscles and orbital fat tissues. The incidence of adverse events was low. CONCLUSION: Teprotumumab N01 infusions result in proptosis response and clinical activity improvements accompanied with favorable safety profile in TED patients who had failed glucocorticoids. Randomized controlled trials will be conducted to further assess the efficacy and safety of teprotumumab N01 in TED patients.
SN  - 2222-3959
SN  - 2227-4898
ER  -